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The ICALIC 2 International Multicentric Study

NCT ID: NCT03947294

Last Updated: 2021-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

137 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-07

Study Completion Date

2021-06-02

Brief Summary

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Clinicians need to measure energy expenditure (EE) by indirect calorimetry (IC) to optimize nutritional support for a better clinical outcome, especially in patients with chronic conditions or with high risk of under- and over- feeding. However, IC is rarely used in clinical routine because the devices currently on the market are of tedious use, imprecise and expensive. An easy-to-use, accurate and inexpensive IC device (Q-NRG® CE marking n°MED 9811) has been developed to meet specifications made by and for clinicians. The ease of use of this new IC device has been first evaluated in mechanical ventilation mode. This second phase aims at evaluating the ease of use, the stability and the feasibility of the measurements with this new IC device in canopy and face mask modes for spontaneously breathing adult patients.

Detailed Description

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This study aims at evaluating the ease of use, the stability and the feasibility of EE measurements with the new IC device in spontaneously breathing adult patients with malnutrition, cancer, surgery or haemodialysis, using the canopy and face mask modes.

Patient data will be obtained from the medical records before EE measurement. EE measurement will be performed sequentially with the Q-NRG® and the IC device currently used in each study center. Patient data input, calibration, installation of face mask or canopy hood on the patient, and EE measurement recording will be performed according to the procedure stated in their respective user manual. Time needed to perform EE will be calculated afterwards from the time the IC device is turned on to EE measurement reaches a steady state with a variation ≤10%.

In a subset of 15 subjects, accuracy of gas composition (O2 and CO2) measurement by the Q-NRG® will be assessed by comparison with the reference method consisting in a mass spectrometer.

Conditions

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Cancer Surgery Hemodialysis

Keywords

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Indirect calorimetry Energy expenditure VO2 VCO2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Q-NRG®

Energy expenditure measurements

Intervention Type DEVICE

Other Intervention Names

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Currently used calorimeters

Eligibility Criteria

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Inclusion Criteria

All spontaneously breathing adult patients (≥ 18 years) referred to the Nutrition Unit in the context of malnutrition, cancer, surgery or haemodialysis.

Exclusion Criteria

1. \< 18 years
2. Intolerance or phobia to canopy or face mask
3. Physical agitation or activity (\< 1hr before EE measurement)
4. Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prof. Claude Pichard

OTHER

Sponsor Role lead

Responsible Party

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Prof. Claude Pichard

Head, Clinical Nutrition

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Geneva University Hospital

Geneva, Geneva 14, Switzerland

Site Status

Countries

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Switzerland

References

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Dupertuis YM, Delsoglio M, Hamilton-James K, Berger MM, Pichard C, Collet TH, Genton L. Clinical evaluation of the new indirect calorimeter in canopy and face mask mode for energy expenditure measurement in spontaneously breathing patients. Clin Nutr. 2022 Jul;41(7):1591-1599. doi: 10.1016/j.clnu.2022.05.018. Epub 2022 May 27.

Reference Type DERIVED
PMID: 35671611 (View on PubMed)

Other Identifiers

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2019-00106

Identifier Type: -

Identifier Source: org_study_id